More great news for men with advanced prostate cancer that is castrate resistant and who also have symptomatic bone metastases and no known visceral metastatic disease. Today, Bayer HealthCare announced that the U.S. Food and Drug Administration (FDA) has approved (radium Ra 223 dichloride).
Xofigo (zo-FEE-go) is the first and only alpha particle-emitting radioactive therapeutic agent approved by the FDA that has demonstrated improvement in overall survival (OS) and delay in time to first symptomatic skeletal event (SSE) compared to placebo, as shown in their pivotal Phase III ALSYMPCA trial.
Bayer says that the commercial production of Xofigo is underway, and first doses are expected to be ready for patient treatment within a few weeks. Bayer has worldwide exclusive marketing rights for Xofigo. It looks to me that my earlier statements about the prior slow down in product availability for the early access trials was correct. However, I can only hope now that the FDA has approved Xofigo® that the product will flow easily to men in need.
Oliver Sartor, MD, North American Principal Investigator for the pivotal trial and medical director of the Tulane Cancer Center said that “Xofigo has demonstrated an antitumor effect on bone metastases and will be an important addition to the treatment of this cancer.” I cannot agree more with him.
We know that bone is the most common site in the body to be affected by metastatic prostate cancer and that bone metastases are particularly prevalent. In reality, approximately 90% of men with metastatic prostate cancer show evidence of bone metastases. Bone metastases can lead to an increase in frequency of skeletal events and are shown to be the main cause of morbidity and death in men with CRPC.
The most common (greater than or equal to 10%) adverse side effects reported from the ALSYMPCA trial were nausea, diarrhea, vomiting and peripheral edema. The most common hematologic laboratory abnormalities (greater than or equal to 10%) were anemia, lymphocytopenia, leukopenia, thrombocytopenia and neutropenia.
Now we wait to see if Bayer is able to deliver the product.
Joel T Nowak, M.A., M.S.W.